Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes

Drug Reactions Clinical Trial

Official title:

Interventional, Open-label, Multiple-dose Study to Investigate the Effects of Multiple Doses of Lu AF35700 on the Pharmacokinetics of Cytochrome P450 (CYP450) Substrates Dextromethorphan (CYP2D6), Caffeine (CYP1A2), Omeprazole (CYP2C19), and Midazolam (CYP3A4/5) in Healthy Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195946
• Other study ID #: 17200A
• Secondary ID: 2016-003187-39
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2017
• Last updated: January 5, 2018
• Start date: June 16, 2017
• Est. completion date: January 3, 2018

Study information

• Verified date: January 2018
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will help determine which types of drugs that may interact with Lu AF35700

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 3, 2018
• Est. primary completion date: January 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Body weight at least 50 kg and Body Mass Index 19 - 30 kg/m2

• Good general health ascertained by a detailed medical history, laboratory tests and physical examination

Exclusion Criteria:

-Pregnant or lactating women

Other protocol defined inclusion and exclusion criteria may apply

Related Conditions & MeSH terms

• Drug Reactions
• Drug-Related Side Effects and Adverse Reactions

Intervention

Drug:
• Lu AF35700
tablets for oral use, 10 mg/day
• Midazolam
syrup for oral use, 4mg/day
• Cocktail of CYP450 substrates
Caffeine tablets for oral use, 200 mg/day. Omeprazole tablets for oral use, 40 mg/day. Dextromethorphan tablets for oral use, 30 mg/day. Midazolam IV solution for Intravenous use, 0.025 mg/kg/day

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit Ltd	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC(0-inf): Area under the plasma concentration-time curve from zero to infinity	Area under the plasma concentration-time curve from zero to infinity for oral midazolam and metabolite and all drug cocktail components and their metabolites	Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for cocktail components.
Primary	Cmax: Maximum observed concentration	Maximum observed concentration of oral midazolam and all drug cocktail components and their metabolites	Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for Cocktail components.